SIST EN ISO 11334-1:2007

SLOVENSKI STANDARD
SIST EN ISO 11334-1:2007
01-julij-2007
1DGRPHãþD
SIST EN ISO 11334-1:2000
3ULSRPRþNL]DKRMRNLVHXSUDYOMDMR]HQRURNR=DKWHYHLQSUHVNXVQHPHWRGH
GHO3RGODNWQHEHUJOH,62
Assistive products for walking manipulated by one arm - Requirements and test methods
- Part 1: Elbow crutches (ISO 11334-1:2007)
Gehhilfen für einarmige Handhabung - Anforderungen und Prüfverfahren - Teil 1:
Unterarmgehstützen (ISO 11334-1:2007)
Produits d'assistance a la marche manipulés avec un bras - Exigences et méthodes
d'essai - Partie 1: Cannes a appui antibrachial (ISO 11334-1:2007)
Ta slovenski standard je istoveten z: EN ISO 11334-1:2007
ICS:
11.180.10 3ULSRPRþNLLQSULODJRGLWYH]D Aids and adaptation for
JLEDQMH moving
SIST EN ISO 11334-1:2007 en;fr;de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 11334-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2007
ICS 11.180.10 Supersedes EN ISO 11334-1:1997
English Version
Assistive products for walking manipulated by one arm -
Requirements and test methods - Part 1: Elbow crutches (ISO
11334-1:2007)
Produits d'assistance à la marche manipulés avec un bras - Gehhilfen für einarmige Handhabung - Anforderungen und
Exigences et méthodes d'essai - Partie 1: Cannes à appui Prüfverfahren - Teil 1: Unterarmgehstützen (ISO 11334-
antibrachial (ISO 11334-1:2007) 1:2007)
This European Standard was approved by CEN on 20 January 2007.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11334-1:2007: E
worldwide for CEN national Members.

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EN ISO 11334-1:2007 (E)





Foreword


This document (EN ISO 11334-1:2007) has been prepared by Technical Committee ISO/TC 173
"Technical systems and aids for disabled or handicapped persons" in collaboration with
Technical Committee CEN/TC 293 "Assistive products for persons with disability", the secretariat
of which is held by SIS.

This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by August 2007, and conflicting national
standards shall be withdrawn at the latest by August 2007.

This document supersedes EN ISO 11334-1:1997.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.


Endorsement notice

The text of ISO 11334-1:2007 has been approved by CEN as EN ISO 11334-1:2007 without any
modifications.

2

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INTERNATIONAL ISO
STANDARD 11334-1
Second edition
2007-02-01

Assistive products for walking
manipulated by one arm — Requirements
and test methods —
Part 1:
Elbow crutches
Produits d'assistance à la marche manipulés avec un bras —
Exigences et méthodes d'essai —
Partie 1: Cannes à appui antibrachial




Reference number
ISO 11334-1:2007(E)
©
ISO 2007

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ISO 11334-1:2007(E)
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©  ISO 2007
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ii © ISO 2007 – All rights reserved

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ISO 11334-1:2007(E)
Contents Page
Foreword. iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Requirements . 6
4.1 Cuff. 6
4.2 Handgrip . 6
4.3 Leg section and tip . 6
4.4 Adjusting devices . 6
4.5 Materials . 6
4.6 Mechanical durability . 7
5 Test methods. 7
5.1 General. 7
5.2 Testing environment. 7
5.3 Sampling. 7
5.4 Forearm withdrawal test . 7
5.5 Separation tests . 8
5.6 Static loading test. 10
5.7 Fatigue test. 12
5.8 Low temperature falling test. 12
5.9 Final inspection. 12
6 Information supplied by the manufacturer . 12
6.1 General. 12
6.2 Information marked on the product. 13
6.3 Documentation. 13
7 Test report . 14
Annex A (informative) Recommendations. 15
Bibliography . 17

© ISO 2007 – All rights reserved iii

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ISO 11334-1:2007(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11334-1 was prepared by Technical Committee ISO/TC 173, Assistive products for persons with disability.
This second edition cancels and replaces the first edition (ISO 11334-1:1994), which has been technically
revised.
ISO 11334 consists of the following parts, under the general title Assistive products for walking manipulated
by one arm — Requirements and test methods:
⎯ Part 1: Elbow crutches
⎯ Part 4: Walking sticks with three or more legs

iv © ISO 2007 – All rights reserved

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INTERNATIONAL STANDARD ISO 11334-1:2007(E)

Assistive products for walking manipulated by one arm —
Requirements and test methods —
Part 1:
Elbow crutches
1 Scope
This part of ISO 11334 specifies requirements and test methods for elbow crutches fully equipped with
handgrip and tip. The methods specify testing of separation, static load capacity, fatigue and resistance to low
temperature embrittlement.
This part of ISO 11334 also gives the requirements relating to safety, ergonomics, performance, and
information to be supplied by the manufacturer, including marking and labelling.
The requirements and tests are based on every-day usage of elbow crutches when performing the through-
swing gait, for a maximum user mass as specified by the manufacturer. This part of ISO 11334 is applicable to
elbow crutches specified for a user mass of not less than 35 kg.
Requirements and test methods for friction of rubber tips against the walking surface are dealt with separately.
NOTE The recommendations given in Annex A supplement the requirements given in this part of ISO 11334.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 9999, Assistive products for persons with disabilities — Classification and terminology
EN 1041, Information supplied by the manufacturer with medical devices
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
3.1
elbow crutch
assistive product for walking with one leg, a handle and a non-horizontal forearm support
See Figure 1.
NOTE Classification no. 12 03 06, according to ISO 9999.
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ISO 11334-1:2007(E)
3.2
handle
part of the crutch to which the handgrip is attached
3.3
handgrip
part of the crutch which is intended by the manufacturer to be held by the hand when the crutch is in use
See Figure 1, item 5.
3.4
handgrip length
h
dimension of the handgrip measured longitudinally where the hand rests, starting at the lowest point as near
as possible to the front stop of the handgrip, and ending at the point as near as possible to the rear stop and
at the shortest possible distance from the tip
See Figures 1 and 2.
NOTE If there is no rear stop, the maximum handgrip length is 110 mm.
3.5
front handgrip reference point
lowest point next to the front stop where the handgrip length starts
See Figure 1, item 7 and Figure 2, item 6.
3.6
rear handgrip reference point
point next to the rear stop where the handgrip length stops
See Figure 1, item 8 and Figure 2, item 7.
3.7
handgrip support line
line drawn through the front and the rear handgrip reference points
See Figure 1, item 6 and Figure 2, item 4.
3.8
handgrip width
width of the handle measured horizontally at the thickest part of the handgrip where the hand rests
See Figure 2, item 5.
3.9
datum
point on the upper surface of the handgrip measuring one-third of the length from the rear handgrip reference
point
See Figure 2, item 3.
3.10
arm section
part of the crutch which is above the rear handgrip reference point
3.11
leg section
part of the crutch which is below the rear handgrip reference point
2 © ISO 2007 – All rights reserved

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ISO 11334-1:2007(E)
3.12
cuff
forearm support as used on an elbow crutch to hold the forearm in the correct position and prevent sideways
movement
See Figure 1, item 2.
3.13
cuff support line
line drawn from the rear handgrip reference point and touching the inside rear bottom face of the cuff at
maximum extension of the arm section
See Figure 1, item 1 and Figure 2, item 1.
3.14
cuff internal width
y
maximum internal dimension of the cuff measured left to right
See Figure 3.
3.15
cuff internal depth
x
internal dimension of the cuff measured front to back
See Figure 3.
3.16
cuff internal height
z
inside measurement of the cuff which is approximately parallel to the cuff support line and which supports the
forearm
See Figure 2.
3.17
tip
part of the crutch which is in contact with the ground
See Figure 1, item 3.
3.18
leg section axis
line drawn from the rear handgrip reference point and through the centre of the tip at maximum extension of
the leg section
See Figure 1, item 4.
3.19
arm section length
a
distance measured between the rear handgrip reference point and the highest point where the cuff support
line touches the inside rear face of the cuff
See Figure 1.
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ISO 11334-1:2007(E)
3.20
leg section length
l
distance measured between the rear handgrip reference point and the centre of the bottom of the tip
See Figure 1.

Key
1 cuff support line 7 front handgrip reference point
2 cuff 8 rear handgrip reference point
a arm section length
3 tip
4 leg section axis h handgrip length
5 handgrip l leg section length
6 handgrip support line
α support angle
β grip angle
Figure 1 — Example of an elbow crutch
4 © ISO 2007 – All rights reserved

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ISO 11334-1:2007(E)

Key
1 cuff support line 6 front handgrip reference point
2 wrist hinge point 7 rear handgrip reference point
3 datum h handgrip length
4 handgrip support line z cuff internal height
a
5 handgrip width
Parallel.
Figure 2 — Details of an elbow crutch


Key
x cuff internal depth
y cuff internal width
Figure 3 — Cuff dimensions
© ISO 2007 – All rights reserved 5

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ISO 11334-1:2007(E)
3.21
support angle
α
angle formed by the leg section axis and the cuff support line
See Figure 1.
3.22
grip angle
β
angle formed by the cuff support line and the handgrip support line
See Figure 1.
...